ClearanceBrief
Panels › Gastroenterology, Urology › Product code FAJ · Class 2

Cystoscope And Accessories, Flexible/Rigid

Regulation 876.1500

5510(k)s in 12 months (92 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
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Top companies in FAJ

Company510(k)sRecalls
KARL STORZ Endoscopy-America, Inc.80
Medivators, Inc.17
Uroviu Corporation70
Shirakawa Olympus Co., Ltd.06
Ambu A/S50
Customed, Inc.13
Guangzhou Red Pine Medical Instrument Co., Ltd.30
V. Mueller O.V. Baxter Healthcare Corp.30
Vision-Sciences, Inc.30
Acmi Corporation20
Decided510(k)Device and applicantCode
May 21, 2026K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (W
Olympus Winter & Ibe GmbH, DE
FAJ
May 11, 2026K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor
Verathon Medical (Canada) Ulc, CA
FAJ
Apr 16, 2026K253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autocla
Strauss Surgical USA
FAJ
Apr 7, 2026K253905PrimeSight UltraView System
Cogentix Medical, Inc.
FAJ
Mar 27, 2026K260271Strauss Surgical cystoscope, hysteroscope and accessories Instruments
American Medical Endoscopy, Inc.
FAJ
Oct 23, 2025K253226UV5000W Handle
Uroviu Corporation
FAJ
Sep 23, 2025K251140Zenflow Spring Scope
Zenflow, Inc.
FAJ
Sep 15, 2025K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Shanghai AnQing Medical Instrument Co., Ltd., CN
FAJ
Sep 11, 2025K250797UV5000 Handle
Uroviu Corporation
FAJ
Aug 13, 2025K243653KARL STORZ HOPKINS Telescopes for Urology
Karl Storz SE & CO. KG, DE
FAJ
Aug 8, 2025K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FAJ
Aug 1, 2025K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA
American Medical Endoscopy, Inc.
FAJ
Jun 11, 2025K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
Ambu A/S, DK
FAJ
Dec 18, 2024K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Dig
Hunan Vathin Medical Instrument Co., Ltd., CN
FAJ
Dec 13, 2024K243196Uro-G HD Cystoscope (1520)
Uroviu Corporation
FAJ
Oct 16, 2024K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2
Ambu A/S, DK
FAJ
Oct 10, 2024K240848Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance
Ambu A/S, DK
FAJ
Aug 22, 2024K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)
Lina Medical Aps, DK
FAJ
Jul 12, 2024K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FAJ
Jun 21, 2024K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FAJ
Jun 10, 2024K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-
MacroLux Medical Technology Co., Ltd., CN
FAJ
Jun 7, 2024K232837Uro-G HD Flexible Cystoscope
Uroviu Corporation
FAJ
Nov 13, 2023K231118Cystoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd., CN
FAJ
Oct 6, 2023K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
Medimaging Integrated Solution, Inc (Miis), CN
FAJ
Sep 29, 2023K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
OTU Medical, Inc.
FAJ
Mar 1, 2023K223040Endo SmartCap
Medivators, Inc.
FAJ
Jan 20, 2023K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CY
Olympus Medical Systems Corporation, JP
FAJ
Dec 29, 2022K221690OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
Olympus Medical Systems Corp., JP
FAJ
Nov 18, 2022K221580Single-Use Flexible Cystoscope
Hunan Vathin Medical Instrument Co., Ltd., CN
FAJ
Nov 9, 2022K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Shanghai AnQing Medical Instrument Co., Ltd., CN
FAJ
Sep 26, 2022K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and
Zhuhai Pusen Medical Technology Co., Ltd., CN
FAJ
Apr 13, 2022K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
OTU Medical, Inc.
FAJ
Sep 3, 2021K212476KARL STORZ Flexible HD Cysto-Urethroscope System
Karl Storz Endoscopy America, Inc.
FAJ
Jun 30, 2021K210512LUMINELLE DTx System
Uvision360, Inc.
FAJ
May 4, 2021K202921Uro-G Cystoscope
Uroviu Corporation
FAJ
Oct 29, 2020K202957Flexible Video Cysto-Urethroscope (C-view)
KARL STORZ Endoscopy-America, Inc.
FAJ
Apr 2, 2020K193095Ambu aScope 4 Cysto
Ambu A/S, DK
FAJ
Sep 18, 2019K191357Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy-America, Inc.
FAJ
Jul 2, 2019K182876Uro-N Cystoscope
Uroviu Corporation
FAJ
Apr 23, 2019K182723Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy-America, Inc.
FAJ
Aug 16, 2018K181909Luminelle DTx Hysteroscopy System
Uvision360, Inc.
FAJ
Jan 30, 2018K171500Uro-V Cystoscope
Uroviu Corporation
FAJ
Dec 19, 2017K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystosco
Solace Therapeutics, Inc.
FAJ
Dec 7, 2017K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.
Henke-Sass, Wolf GmbH, DE
FAJ
Aug 17, 2016K160766Ambu USR, Ambu M
Ambu A/S, DK
FAJ
Dec 19, 2014K142194CytoSure Urinary Access System
Emmy Medical
FAJ
Sep 11, 2012K120766ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
Prosurg, Inc.
FAJ
Aug 30, 2010K093725CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
Canada Endoscope Corporation, CA
FAJ
Dec 15, 2009K093665ENDO SMARTCAP
Byrne Medical, Inc.
FAJ
Apr 20, 2009K090814MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
Gyrus Acmi, Inc.
FAJ

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